Home / Recalls / Medtronic Navigation, Inc. / Z-1693-2020

Z-1693-2020 Class II Terminated

Recalled by Medtronic Navigation, Inc. — Louisville, CO

Recall Details

Product Type
Devices
Report Date
April 22, 2020
Initiation Date
August 28, 2019
Termination Date
May 5, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

NavLock Tracker *** Rx Only

Reason for Recall

Product was incorrectly assembled which could affect navigation accuracy of the device.

Distribution Pattern

U.S.: NY No O.U.S.

Code Information

Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585

Other recalls by Medtronic Navigation, Inc.

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  • Z-0699-2024 Class II — Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS (November 28, 2023)
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  • Z-0188-2024 Class I — StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Stealt (September 27, 2023)
  • Z-1666-2023 Class I — StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 (April 11, 2023)
  • Z-1630-2023 Class I — StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), (April 11, 2023)
  • Z-1039-2023 Class II — AxiEM" Non-Invasive Patient Tracker (December 15, 2022)
  • Z-0953-2023 Class II — RadiaLux Lighted Retractor (Pink), REF: 50-101-1 (December 8, 2022)